Atazanavir Twice Daily

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357721
First received: July 25, 2006
Last updated: April 5, 2011
Last verified: April 2011

July 25, 2006
April 5, 2011
June 2006
September 2006   (final data collection date for primary outcome measure)
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Same as current
Complete list of historical versions of study NCT00357721 on ClinicalTrials.gov Archive Site
  • Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
  • Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
  • Assess the effect of atazanavir BID on metabolic parameters
  • Assess the safety and tolerability of atazanavir when administered BID
Same as current
Not Provided
Not Provided
 
Atazanavir Twice Daily
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • HIV Infections
  • Protease Inhibitor
  • Drug: Atazanavir Sulphate
    Capsules, Oral, 200 mg, twice daily, 7 days.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate
    Capsules, Oral, 300 mg, twice daily, 8 days.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate
    Capsules, Oral, 400 mg, twice daily, 9 days.
    Other Name: Reyataz
  • Active Comparator: A1
    Intervention: Drug: Atazanavir Sulphate
  • Active Comparator: A2
    Intervention: Drug: Atazanavir Sulphate
  • Active Comparator: A3
    Intervention: Drug: Atazanavir Sulphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357721
AI424-286
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP